P03 Sole Source Justification Surgical Instrument PM.pdf

Acquisition ID#: 36C248-26-AP-1845

DEPARTMENT OF VETERANS AFFAIRS

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Acquisition Plan Action ID: 36C248-26-AP-1845

2. Contracting Activity: Department of Veterans Affairs

VISN 8, Network Contracting Office (NCO-8) North Florida/South Georgia VHS (573) 1601 SW Archer Road Gainesville, FL 32608-1197

3. Nature and/or Description of the Action Being Processed: This action is for a firm-fixed-price contract (base plus one option year) for preventive maintenance (PM) and emergency repair services for Stryker brand surgical instruments owned and maintained by Surgical Service within

NFSG VHS.

4. Description of Supplies/Services Required to Meet the Agency’s Needs: The NFSG VHS requires OEM-certified preventive maintenance and emergency repair services for Stryker surgical instruments used daily in surgical procedures.

Estimated Value: $547,159.44

5. Statutory Authority Permitting Restricted Competition: FAR 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements.

6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Stryker Corporation is the OEM and the only entity authorized to perform maintenance and repairs on its surgical instruments.

Proprietary technology and designs are not shared with third parties. Stryker does not sell repair components or train outside vendors. Use of unauthorized vendors risks non-compliance with OEM safety and sterility standards, voiding of certifications, and increased liability.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research confirmed no other sources are authorized to perform these services. A notice will be posted on SAM.gov in accordance with FAR Part 5.

8. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The Contracting Officer will compare pricing to historical data and OEM published rates to ensure cost reasonableness.

9. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: SBA and SAM.gov searches identified SDVOSBs under NAICS 811210, but none are authorized by Stryker. FPDS and ADDS UP searches show historical awards for similar services were sole-sourced to OEMs. GSA eLibrary lists equipment but not maintenance services. Conclusion: Only Stryker can meet this requirement.

Acquisition ID#: 36C248-26-AP-1845

10. Any Other Facts Supporting the Use of Other than Full and Open Competition: Third-party repairs cannot guarantee sterility or compliance with OEM standards. OEM-trained technicians ensure patient safety and maintain liability protections.

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No sources other than

Stryker expressed interest in writing.

12. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

None identified; OEM restrictions prevent competition.

13. Procurement History and Cost Duplication: A review of procurement history indicates that previous contracts for similar Stryker surgical instrument maintenance were awarded to the OEM. If another vendor attempted to provide these services, the Government would incur significant duplication of cost for training, tooling, and compliance validation.

14. Certification:

a. Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Heidi Parrish Contracting Officer

NCO-8